Epoetin Alfa

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Treatment of anemia in patients with chronic renal failure

Adult Hemodialysis Patients

Eralfon® is injected subcutaneously or intravenously at the end of a dialysis session. When changing the method of administration, the drug is administered in the same dose, then the dose is adjusted if necessary (with the subcutaneous method of drug administration, a dose of 20-30% less is required to achieve the same therapeutic effect than with intravenous administration). Drug treatment involves two stages:

1. Stage of correction: upon subcutaneous administration of the drug, the initial single dose is 30 IU / kg 3 times a week. With intravenous administration of the drug, the initial single dose is 50 IU / kg 3 times a week. The correction period lasts until the optimal hemoglobin level is reached (100-120 g / l in adults and 95-110 g / l in children) and hematocrit (30-35%). These indicators need to be monitored weekly.

The following situations are possible:

1) Hematocrit rises from 0.5 to 1.0% per week. In this case, the dose does not change until the optimum performance.

2) The rate of hematocrit increase is less than 0.5% per week. In this case, it is necessary to increase the single dose by 1.5 times.

3) Growth rate of more than 1.0% per week. In this case, it is necessary to reduce a single dose of the drug by 1.5 times.

4) Hematocrit remains low or decreases. It is necessary to analyze the causes of resistance before increasing the dose of the drug.

The effectiveness of therapy depends on the correctly selected individual treatment regimen.

Stage of maintenance therapy: to maintain hematocrit at the level of 30-35%, the dose of the drug used at the correction stage should be reduced by 1.5 times. Then, the maintenance dose of the drug is selected individually, taking into account the dynamics of hematocrit and hemoglobin levels.

In children on hemodialysis, the initial dose is 50 U / kg 3 times a week. If necessary, a single dose is increased 1 time per 4 weeks at 25 U / kg until the optimum hemoglobin concentration is reached. Maintenance dose in children weighing less than 10 kg - 75-150 U / kg (average 100 U / kg) 3 times a week, 10-30 kg - 60-150 U / kg (average 75 U / kg) 3 Once a week, more than 30 kg - 30-100 U / kg (on average 33 U / kg) 3 times a week.

For predialysis adult patients, the initial dose is administered subcutaneously or intravenously 3 times 50 U / kg per week. If necessary, a single dose is increased once every 4 weeks at 25 U / kg until the optimum hemoglobin concentration is reached.

Maintenance dose - 17-33 U / kg 3 times a week.

Prevention and treatment of anemia in patients with solid tumors

Before starting treatment, it is recommended to determine the level of endogenous erythropoietin. When the concentration of serum erythropoietin is less than 200 IU / ml, the initial dose of the drug for intravenous administration is 150 IU / kg 3 times a week. If after 4 weeks of treatment the hemoglobin level has increased and is not less than 10 g / l or the number of reticulocytes has increased by more than 40,000 cells / mcl above the initial level, then the dose of the drug remains the same (150 IU / kg body weight 3 times a week).

If, after 4 weeks of treatment, an increase in hemoglobin level is less than 10 g / l and an increase in the number of reticulocytes is less than 40,000 cells / μl as compared to the initial level, then over the next 4 weeks the dose is increased to 300 IU / kg body weight 3 times a week . If after an additional 4 weeks of treatment with a dose of 300 IU / kg, the hemoglobin level has increased and is not less than 10 g / l or the number of reticulocytes has increased by more than 40,000 cells / mcl, then the existing dose of the preparation is maintained (300 IU / kg of body weight 3 times a week). If after 4 weeks of treatment at a dose of 300 IU / kg body weight, the hemoglobin level rises by less than 10 g / l and the increase in the number of reticulocytes is less than 40,000 cells / mcl compared to the initial level, treatment should be stopped.In the case of an increase in hemoglobin level of more than 20 g / l during the month, the dose of the drug must be reduced by 25%. If the hemoglobin level exceeds 140 g / l, it is necessary to suspend treatment until the hemoglobin level drops below 120 g / l and then continue the administration of the drug at a dose 25% lower than the initial one.

Drug therapy should continue for one month after the end of chemotherapy.

Serum ferritin level (or serum iron level) must be determined in all patients before and during the treatment with the drug. If necessary, an additional iron supplement is prescribed.

Prevention and treatment of anemia in patients with HIV infection

It is recommended to determine the initial level of endogenous erythropoietin in blood serum prior to treatment with Eralfon®. Studies show that when the level of erythropoietin is more than 500 IU / ml, the effect of drug therapy is unlikely.

1. Stage of correction: the drug is administered at a dose of 100 IU / kg 3 times a week subcutaneously or intravenously for 8 weeks. If after 8 weeks of treatment it was not possible to achieve a satisfactory effect (for example, to reduce the need for blood transfusions or to increase the level of hemoglobin), the dose can be increased gradually (no more than once every 4 weeks) by 50-100 IU / kg 3 times a week If it was not possible to achieve a satisfactory effect of therapy with Eralfon® at a dose of 300 IU / kg 3 times a week, then the appearance of a response to further therapy at higher doses is unlikely.

2. Stage of maintenance therapy: after achieving a satisfactory effect in the correction phase of anemia, the maintenance dose should provide a hematocrit between 30-35% depending on changes in the dose of zidovudine, the presence of concomitant infectious or inflammatory diseases. With a hematocrit of more than 40%, the administration of the drug should be discontinued until the hematocrit is reduced to 36%. When therapy is resumed, the dose of epoetin alfa should be reduced by 25%, followed by adjustment to maintain the desired hematocrit. Serum ferritin level (or serum iron level) must be determined in all patients before and during the treatment with the drug. If necessary, an additional iron supplement is prescribed.

Prevention and treatment of anemia in patients with myeloma, low-grade non-Hodgkin's lymphomas and chronic lymphatic leukemia In these patients, the efficacy of treatment with epoetin alfa is due to inadequate synthesis of endogenous erythropoietin in the presence of anemia.

With a hemoglobin level below 100 g / l and serum erythropoietin below 100 IU / ml, Eralfon® is administered subcutaneously at a starting dose of 100 IU / kg three times a week.

Laboratory monitoring of hemodynamic parameters is carried out weekly. If necessary, the dose of the drug is adjusted in the direction of increasing or decreasing every 3-4 weeks. If, upon reaching a weekly dose of 600 IU / kg, an increase in hemoglobin level is not observed, further use of epoetin alfa should be canceled as ineffective.

Prevention and treatment of anemia in patients with rheumatoid arthritis

In patients with rheumatoid arthritis, suppression of the synthesis of endogenous erythropoietin is observed under the influence of an increased concentration of anti-inflammatory cytokines. Treatment of anemia in these patients is carried out with a subcutaneous injection at a dose of 50-75 IU / kg 3 times a week. With an increase in hemoglobin level of less than 10 g / l after 4 weeks of treatment, the dose of the drug is increased to 150-200 IU / kg 3 times a week. Further increase in dose seems inappropriate.

Treatment and prevention of anemia in premature babies born with low birth weight

Eralfon® is administered subcutaneously at a dose of 200 IU / kg three times a week, starting from the 6th day of life, until the hemoglobin and hematocrit levels are achieved, but not more than 6 weeks.

Adult patients participating in the autologous blood collection program before surgery

It is recommended to use intravenous drug. Epoetin alfa should be administered at the end of the blood collection procedure. Before the appointment of the drug should take into account all contraindications to the collection of autologous blood. Before surgery, Eralfon® should be administered 2 times a week for 3 weeks. Each time a doctor visits a patient, they take a portion of blood (if hematocrit is> 33% and / or hemoglobin level is> 110 g / l) and is retained for autologous transfusion. The recommended dose of Eralfon® is 600 IU / kg body weight 2 times a week. Serum ferritin level (or serum iron level) must be determined in all patients before and during the treatment with the drug. If necessary, an additional iron supplement is prescribed.

If anemia is present, its cause must be established before initiating epoetin alfa therapy. It is necessary as soon as possible to ensure an adequate intake of iron in the body, by administering an oral iron supplement in a dose of 200 mg / day (based on divalent iron) and to maintain iron intake at this level throughout the entire course of therapy. Patients in the pre- and postoperative period not participating in the autologous blood collection program

It is recommended to use subcutaneous administration of the drug in a dose of 600 IU / kg body weight per week for 3 weeks preceding the operation (21st, 14th and 7th days before the operation), and on the day of the operation. If necessary, when medically necessary to reduce the preoperative period, Eralfon® can be administered daily at a dose of 300 IU / kg body weight for 10 days before surgery, on the day of surgery, and for 4 days after surgery. If the hemoglobin level in the preoperative period reaches 150 g / l and higher, the use of epoetin alfa should be discontinued. Before starting therapy with epoetin alfa, it is necessary to make sure that there is no iron deficiency in patients.

All patients should receive an adequate amount of iron (oral 200 mg / day based on ferrous iron) throughout the course of treatment. If possible, additional oral iron intake should be provided prior to initiating epoetin alfa therapy to ensure adequate iron stores in the patient's body.

Adverse reactions

At the beginning of treatment, flu-like symptoms may occur: dizziness, drowsiness, fever, headache, myalgia, arthralgia.

Since the cardiovascular system: a dose-dependent increase in blood pressure, worsening of hypertension (most often in patients with chronic renal failure), in some cases - hypertensive crisis, a sharp increase in blood pressure with symptoms of encephalopathy (headache, confusion) and generalized tonic-clonic convulsions.

From the side of blood formation organs: thrombocytosis, in some cases - thrombosis of a shunt or arteriovenous fistula (in patients on hemodialysis with a tendency to hypotension or with aneurysm, stenosis, etc.), erythrocyte germ aplasia.

Allergic reactions: skin rash (mild or moderate), eczema, urticaria, pruritus, angioedema.

Local reactions: hyperemia, burning, weak or moderate pain at the site of administration (most often occur with subcutaneous administration).

From the laboratory parameters: a decrease in the concentration of ferritin in the serum, with uremia - hyperkalemia, hyperphosphatemia.

Other: complications associated with impaired respiration or a decrease in blood pressure, immune reactions (induction of antibody formation), exacerbation of porphyria.

Contraindications

- Hypersensitivity to the drug, or its components;

- partial red cell aplasia after previous treatment with any erythropoietin;

- uncontrolled arterial hypertension;

- the inability to conduct adequate anticoagulant therapy;

- in case of severe occlusive diseases of the coronary, carotid, cerebral and peripheral arteries and their consequences, including acute and recent myocardial infarction and acute cerebrovascular accident (as part of a pre-posterior blood collection program before surgery).

Carefully:

Malignant neoplasms, epileptic syndrome (including in the presence of a history), thrombocytosis, thrombosis (in history), sickle cell anemia, iron, B12 or foliodeficient states, porphyria, chronic liver failure.

Drug interactions

Reduces the concentration of cyclosporine due to the increase in its binding to red blood cells (it may be necessary to adjust the dose of cyclosporine). Pharmaceutically incompatible with solutions of other drugs.

Pregnancy and Lactation

Special instructions

Overdosage